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Completed

NCT Number: NCT05427773

(In)Voluntary Assessed Quadriceps Muscle Endurance in COPD

The primary objective is to assess the relation between involuntary and voluntary assessed quadriceps muscle endurance in patients with COPD. We hypothesized a good correlation (>0.8) between the measurements.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

About this study

Rationale: Quadriceps muscle endurance is reduced in patients with COPD. However, no consensus has been reached yet on the best method to evaluate quadriceps muscle endurance. One important aspect is the large variety in protocols and devices used around the world. Commonly used and reliable measures are voluntary protocols performed on a computerized dynamometer. However, these voluntary measurements might also be influenced by external factors as patients effort or motivation. Therefore, it is important to evaluate the relation between voluntary and involuntary (i.e. electrical stimulated) assessed quadriceps muscle endurance.

Objective(s): The primary objective is to assess the relation between involuntary and voluntary assessed quadriceps muscle endurance in patients with COPD.

Study design: Cross-sectional observation study.

Study population: 20 COPD patients who perform baseline assessment at the pulmonary rehabilitation centre at Radboudumc (Nijmegen, the Netherlands).

Intervention: not applicable

Main study parameters/endpoints: The primary outcome will be the electrically evoked isometric quadriceps muscle endurance (fatigue resistance) and voluntary isokinetic (work fatigue index5) and isometric quadriceps endurance (time).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: BURDEN: All measurements are part of standard care, except for one questionnaire and (involuntary) electrical assessed quadriceps function. Thus, the additional burden for the patient is one additional measurement of approximately 70 minutes. RISKS: Performance of electrically evoked assessment of muscle function is not associated with a health risk. This procedure is non-invasive and not painful and performed routinely at the department of Physiology (Radboudumc, Nijmegen). Therefore, no safety risk is involved.

BENEFIT: The benefits will be high as it will provide more insight in the relation between voluntary and involuntary assessed quadriceps muscle endurance. This insight is necessary to optimize the clinical assessment of muscle endurance in patients with COPD.

GROUP RELATEDNESS: This will be the first study in which the relation between voluntary and involuntary assessed quadriceps muscle endurance in COPD will be investigated. These results will also be valuable for other diseases/conditions in which isolated muscle endurance should be assessed like asthma, pulmonary hypertension, etc.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD, based on GOLD classification
  • Clinically stable according to the pulmonary physician, i.e. no exacerbation and/or hospitalization within the previous 4 weeks
  • Age between 40-80 years
  • Take part in the pulmonary rehabilitation program at Radboudumc (Nijmegen)

Exclusion criteria

  • Inability to understand the Dutch language
  • Musculoskeletal and neurological problems influencing quadriceps muscle function testing

Treatment and study plan

Primary outcomes

  1. Electrically evoked fatigue resistance (%)

    Time frame: Performed in first week of pulmonary rehabilitation program

    Fatigue resistance (%) is the decline in muscle force generated using electrical stimulation.

  2. Voluntary isometric quadriceps endurance (time to fatigue).

    Time frame: Performed in first week of pulmonary rehabilitation program

    Voluntary isometric quadriceps endurance (time to fatigue in seconds) is determined on the computerized dynamometer. The isometric endurance test protocol is performed by asking participants to maintain, for as long as possible, an isometric quadriceps contraction representing 60% of the individual isometric maximal voluntary contraction (MVC) force. The test will be ended if the force of the contraction was less than 50% of the MVC for three consecutive seconds.

  3. Voluntary isokinetic work fatigue index.

    Time frame: Performed in first week of pulmonary rehabilitation program

    Voluntary isokinetic work fatigue (%) is the decline in work over 30 repetitions determined on the computerized dynamometer. The isokinetic protocol consists of 30 contractions at an angular velocity of 90°/s with maximal effort during extension and passive (submaximal) flexion.

    Work fatigue index = *work first 5 repetitions - work last 5 repetitions) / work first 5 repetitions * 100%

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

(In)Voluntary Assessed Quadriceps Muscle Endurance in Patients With Chronic Obstructive Pulmonary Disease: a Cross-sectional Observation Study.

Acronym: Bionic

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2022
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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